Kissné C E
Országos Gyógyszerészeti Intézet, Budapest.
Acta Pharm Hung. 1990 Nov;60(5-6):191-6.
The author's aim was to compare the dissolution properties of the two newly developed sustained release "A" and "B" tablets containing 3,000 mg and 150 mg theophyllin respectively with the similar foreign preparations on the market. The referent preparations are as follows: Theo-Dur (Astra) and Theo-Dur (Recordati) tablets; Euphyllin and Euphyllin minor (Byk Gulden) retard capsules; Euphyllin retard (Byk Gulden) filmcoated tablets and Aminophyllinum-retard (Lek-Ljubljana) tablets. The dissolution tests were carried out by means of the rotating basket apparatus. The "half-change" method was used for testing the dissolution of the preparations. Evaluating the preparations the optimal dissolution rate found in the literature was taken into consideration. The results of the "B" tablet containing 150 mg theophylline were in good agreement with the findings of the preparations on the market and those indicated in the literature. The "A" tablet containing 300 mg active substance showed significantly slower dissolution rate as the comparative preparation did and as it is regarded optimal by the literature.
作者的目的是将两种新开发的分别含有3000毫克和150毫克茶碱的缓释“A”片和“B”片的溶出特性与市场上类似的国外制剂进行比较。对照制剂如下：Theo-Dur（阿斯特拉公司）和Theo-Dur（雷卡迪公司）片；优菲林和小优菲林（拜耳古德曼公司）缓释胶囊；优菲林缓释（拜耳古德曼公司）薄膜包衣片和氨茶碱缓释（卢布尔雅那莱克公司）片。溶出试验采用转篮法进行。采用“半变化”法测试制剂的溶出度。在评估制剂时，考虑了文献中发现的最佳溶出速率。含150毫克茶碱的“B”片的结果与市场上制剂的结果以及文献中指出的结果高度一致。含300毫克活性物质的“A”片的溶出速率明显低于对照制剂，也低于文献中认为的最佳溶出速率。
